A Study of Oral Venetoclax Tablet in Combination With Subcutaneous Low-Dose Cytarabine (LDAC) Injection to Assess Adverse Events in Adult Japanese Participants With Acute Myeloid Leukemia (AML)

NCT04509622 | Completed Phase 3

• 1 other identifier: M19-916
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 16

Brief Summary

Acute Myeloid Leukemia (AML) is a cancer of the white blood cells which perform many functions, including fighting bacterial infections and defending the body against parasites. This study will evaluate how safe venetoclax is and assess the adverse events in adult participants with AML. Venetoclax in combination with low-dose cytarabine (LDAC) is an approved therapy in the United States for patients with newly diagnosed acute myeloid leukemia (AML) aged \> 18 years with a medical condition that prevents the use of intensive chemotherapy. This study provides access to venetoclax in combination with LDAC to participants over 18 years who are ineligible for intensive induction therapy. Around 38 adult participants with diagnosis of AML will be enrolled in approximately 15 sites across Japan. Participants will receive oral venetoclax tablets once daily on days 1-28 in combination with subcutaneous low-dose cytarabine (LDAC) injections once daily on days 1-10 of the 28-day treatment cycles. Participants will attend regular visits during the study at a hospital to evaluate safety by medical assessments and blood tests.

Conditions

Acute Myeloid Leukemia (AML)

Keywords

Acute Myeloid Leukemia (AML); Cancer; Venetoclax, Venclexta

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.

  Up to approximately 9 months after the first participant receives first dose of study drug

Study Arms (1)

Venetoclax + Low-Dose Cytarabine (LDAC)

EXPERIMENTAL

Participants will receive venetoclax once daily (QD) on days 1 through 28 plus LDAC QD on days 1 through 10 during the 28-day treatment cycles.

Drug: Venetoclax; Drug: Cytarabine

Interventions

Venetoclax DRUG

Tablet; Oral

Also known as: ABT-199, Venclexta

Venetoclax + Low-Dose Cytarabine (LDAC)

Cytarabine DRUG

Subcutaneous Injection

Venetoclax + Low-Dose Cytarabine (LDAC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of AML, previously untreated, ineligible for intensive induction regimen due to age or co-morbidities.
• Participants who are \>= 75 years of age or who are \>= 18 to 74 years of age with at least one of the following co-morbidities:
• Eastern Cooperative Oncology Group (ECOG) performance status of 2 or 3.
• Cardiac history of congestive heart failure requiring treatment or ejection fraction \<= 50% or chronic stable angina.
• Diffusion capacity of lung for carbon monoxide (DLCO) \<= 65% or forced expiratory volume during the first second (FEV1) \<= 65%.
• Adequate renal and hepatic criteria as described in the protocol.
• Other co-morbidities that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the AbbVie Therapeutic Area Medical Director (TA MD) before study enrollment.

You may not qualify if:

• History of prior treatment for AML with the exception of hydroxyurea, allowed through the first cycle of study treatment.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (16)

NHO Nagoya Medical Center /ID# 223671

Nagoya, Aichi-ken, 460-0001, Japan

Location

Aichi Cancer Center Hospital /ID# 223134

Nagoya, Aichi-ken, 464-8681, Japan

Location

University of Fukui Hospital /ID# 223133

Yoshida-gun, Fukui, 910-1193, Japan

Location

Kyushu University Hospital /ID# 223136

Fukuoka, Fukuoka, 812-8582, Japan

Location

Gunmaken Saiseikai Maebashi Hospital /ID# 223301

Maebashi, Gunma, 371-0821, Japan

Location

National Hospital Organization Mito Medical Center /ID# 223392

Higashi Ibaraki-gun, Ibaraki, 311-3193, Japan

Location

Hitachi General Hospital /ID# 223084

Hitachi-shi, Ibaraki, 317-0077, Japan

Location

University Hospital Kyoto Prefectural University of Medicine /ID# 223135

Kyoto, Kyoto, 602-8566, Japan

Location

Tohoku University Hospital /ID# 223169

Sendai, Miyagi, 9808574, Japan

Location

Okayama University Hospital /ID# 222990

Okayama, Okayama-ken, 700-8558, Japan

Location

Osaka City University Hospital /ID# 224269

Osaka, Osaka, 545-8586, Japan

Location

Saitama Medical University International Medical Center /ID# 223575

Hidaka-shi, Saitama, 350-1298, Japan

Location

Juntendo University Hospital /ID# 223086

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

The Jikei University Daisan Hospital /ID# 223418

Komae-shi, Tokyo, 201-8601, Japan

Location

NTT Medical Center Tokyo /ID# 223574

Shinagawa-ku, Tokyo, 141-8625, Japan

Location

Yamagata University Hospital /ID# 223032

Yamagata, Yamagata, 990-9585, Japan

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasms

Interventions

venetoclax; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2020
• First Posted: August 12, 2020
• Study Start: October 5, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: May 5, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.

Locations

JP (16)